Effect of Intravenous Tranexamic Acid on Reduction of Blood Losses in Hip Fracture Patients
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Anemia
- Hip Fractures
- Type
- Interventional
- Phase
- Phase 4
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Patients will be treated surgically with a long trochanteric femoral nail (TFN) or hemiarthroplasty The two patient groups will include: 1) Study group treated with tranexamic acid at the time of surgical incision; 2) Control group treated with placebo injection (saline solution). Blood transfusion criteria will remain consistent with hospital standards. Deep vein thrombosis (DVT) prophylaxis will remain consistent with hospital standards (subcutaneous heparin from admission until 12 hours prior to surgery and beginning 6 hours after surgery). After discharge, ..... Patients will be followed at regular intervals (1mo, 3mo, and at least 6mo) and at each time point the patient will be asked to report any adverse events (DVT, PT, Stroke, myocardial infarction, infection, hospitalization). Diagnostic studies to assess for thromboembolic events (i.e. DVT, pulmonary embolism (PE), and stroke) will be ordered only if the patient develops clinical signs or symptoms that justify their use.Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Masking Description: Patients will be allocated into two groups based on randomized 20-block method by an independent assistant using computer generated randomization. Both patients and the treating surgeons will be blinded with regard to placebo vs. treatment until completion of the studyPrimary Purpose: Treatment
Participation Requirements
- Age
- Between 60 years and 125 years
- Gender
- Both males and females
Description
Candidates for the study will be consecutive patients with a diagnosis of hip fractures treated at our center. All patients with hip fracture meeting inclusion criteria will be recruited for enrollment into the study. Informed consent will be obtained from the patient prior to randomization. At that...
Candidates for the study will be consecutive patients with a diagnosis of hip fractures treated at our center. All patients with hip fracture meeting inclusion criteria will be recruited for enrollment into the study. Informed consent will be obtained from the patient prior to randomization. At that time, each patient will be randomized into one of two groups by a independent staff using computer generated randomization and allocation concealment. The two patient groups will include: Study group: 1g of intravenous tranexamic acid at the time of surgical incision. Control group: placebo injection (saline solution) at the time of surgical incision. Both patients and the treating surgeons will be blinded with regard to placebo vs. treatment until completion of the study. Patients will be treated surgically with a long trochanteric femoral nail (TFN) or hemiarthroplasty. Blood transfusion criteria will remain consistent with hospital standards (Hb<8 g/dL or >9 g/dL if symptomatic anemia). Total number of blood transfusions received will be documented upon patient discharge. Deep vein thrombosis (DVT) prophylaxis will remain consistent with hospital standards (subcutaneous heparin from admission until 12 hours prior to surgery and beginning 6 hours after surgery). After discharge, ..... Patients will be followed at regular intervals (1mo, 3mo, and at least 6mo) and at each time point the patient will be asked to report any adverse events (DVT, PT, Stroke, myocardial infarction, infection, hospitalization). Diagnostic studies to assess for thromboembolic events (i.e. DVT, pulmonary embolism (PE), and stroke) will be ordered only if the patient develops clinical signs or symptoms that justify their use.
Tracking Information
- NCT #
- NCT03211286
- Collaborators
- University of Alicante
- Investigators
- Study Chair: Alejandro Lizaur-Utrilla, PHD, MD Orthopaedic Surgery Department, Elda University Hospital
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